FDA Asks for Comments on Prior Notice Info Collection for Food Importers
The Food and Drug Administration is asking for comments by Dec. 31 on issues related to the collection of information through the prior notice requirement for imported food. The Office of Management and Budget requires agencies to periodically get approval for information they collect from the public. FDA is requesting an extension of approval for its prior notice requirements, and incorporating a change made in 2011 (and adopted in 2013 in final form) that importers must declare any country that has refused their products.
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FDA regulations require that prior notice be submitted electronically through CBP’s Automated Broker Interface (ABI) of the Automated Commercial System (ACS), or the FDA Prior Notice System Interface (PNSI). FDA says it gets many of the required data elements from CBP because they’re required anyway on entry documentation. FDA estimates 15,000 respondents each file 608 prior notices per year, requiring about 10 minutes each, through ABI/ACS. Through PNSI, FDA estimates 26,667 respondents each file 58 responses per year requiring about 23 minutes each. Counting both filing systems, FDA estimates an total annual burden on industry of 2,116,967 hours per year.
FDA is requesting comments on: (1) whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Comments may be submitted to www.regulations.gov, docket no. FDA-2011-N-0179.